A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: Tocilizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01668966

ML28080

Details and patient eligibility

About

This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01007435) will evaluate the safety and efficacy of tocilizumab in participants with early, moderate to severe RA who have completed the 104-week WA19926 (NCT01007435) core study. Eligible participants will be those who are expected to benefit from the study medicine based on the investigator's discretion.

Enrollment

23 patients

Sex

All

Ages

18+ months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants who completed their last WA19926 (NCT01649804) core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
No current or recent adverse event or laboratory finding preventing the use of tocilizumab 8 mg/kg at baseline visit
Women of childbearing potential must agree to use highly reliable contraception during the treatment period

Exclusion criteria

Pregnant or breastfeeding females
Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study for any reason
Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926 (NCT01649804)
Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926 (NCT01649804)
Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926 (NCT01649804)
Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of rheumatic autoimmune disease other than RA
Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of inflammatory joint disease other than RA
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
Evidence of severe uncontrolled concomitant disease or disorder
Known active infections or history of recurrent infections
Active tuberculosis requiring treatment in the previous 3 years
History of alcohol, drug or chemical abuse since inclusion in the WA19926 (NCT01649804) study